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Clinical Trials/NCT06425237
NCT06425237RecruitingNot Applicable

Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography

University Hospital, Rouen1 site in 1 country224 target enrollmentStarted: November 4, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
224
Locations
1
Primary Endpoint
influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.

Study Overview

Brief Summary

Cerebral arteriography is a reference examination in medical imaging. This examination is performed to allow the diagnosis and therapeutic management of patients with vascular pathologies.

It is most often accompanied by a situation of stress, anxiety and apprehension related to the course of the examination or the announcement of the results.

These situations generate physiological reactions in patients, making the performance of cerebral arteriography more complex. In order to improve the quality of care for patients undergoing this invasive examination, it is proposed to use two non-medicinal techniques known for their soothing and relaxing properties: aromatherapy and music therapy alone or in combination. These two techniques will help to establish a common thread from the preparation of the patient before the examination to his return to the post-interventional surveillance room.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult (≥ 18 years old)
  • •Patient who is scheduled for a cerebral arteriography with local anaesthesia
  • •Patient who capable to read and understand the patient information and consent.
  • •Patient capable to read and sign the consent form
  • •Patient with social insurance
  • •Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
  • •Negative urine pregnancy test

Exclusion Criteria

  • •Patients who have had a previous cerebral arteriogram
  • •Patient with allergy to iodinated contrast medium
  • •Patient with severe renal insufficiency
  • •Patient requiring sedation and artificial ventilation
  • •Patient who is deaf and/or hard of hearing
  • •Patient with a known allergy to essential oils
  • •Patient with anosmia
  • •Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,
  • •Pregnant or breastfeeding woman

Arms & Interventions

standard care

No Intervention

standard care and aromatherapy

Experimental

Intervention: aromatherapy (Other)

standard care ansd music therapy and aromatherapy

Experimental

Intervention: music therapy (Other)

standard care ansd music therapy and aromatherapy

Experimental

Intervention: aromatherapy (Other)

standard care and music therapy

Experimental

Intervention: music therapy (Other)

Outcomes

Primary Outcomes

influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.

Time Frame: day 1

blood pressure

Secondary Outcomes

  • hospital anxiety and depression scale(day 1)
  • stress(day 1)
  • level of pain(day 1)
  • Cumulative X-ray dose (mGy/cm2) received by the patient(day 1)

Investigators

Sponsor
University Hospital, Rouen
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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